CLIA IQ/OQ Documentation Specialist Needed | Lab Equipment Validation, Gap Analysis, OQ/IQ Protocols, Audit-Ready Compliance

We are looking for an experienced IQ/OQ documentation and QA/QMS specialist to prepare a complete CLIA-compliant documentation package for two laboratory instruments.

Scope:
Review existing calibration/testing documents
Perform gap assessment
Prepare IQ Protocol, Checklist & Report
Prepare OQ Protocol, Acceptance Criteria & Report
Create evidence traceability matrix
Compile audit-ready calibration/service documentation

Deliverables:
Gap Assessment Summary
IQ & OQ Documentation (Protocols + Reports)
Traceability Matrix
Final audit-ready documentation package

Timeline:
4 Business Days (Strict Deadline)

Requirements:
Experience with IQ/OQ validation & CLIA compliance
Knowledge of lab equipment qualification & QA/QMS systems
Ability to deliver audit-ready documentation